K211125 is an FDA 510(k) clearance for the Novum IQ Syringe Pump. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on August 30, 2022, 502 days after receiving the submission on April 15, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K211125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2021 |
| Decision Date | August 30, 2022 |
| Days to Decision | 502 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |